PMID- 35942408 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220810 IS - 1687-8450 (Print) IS - 1687-8469 (Electronic) IS - 1687-8450 (Linking) VI - 2022 DP - 2022 TI - Clinical Efficacy of PD-1 Inhibitors Plus Split-Course Radiotherapy in the First-Line Treatment of Advanced Kidney Cancer: A Randomized Controlled Trial. PG - 8100323 LID - 10.1155/2022/8100323 [doi] LID - 8100323 AB - OBJECTIVE: To assess the clinical efficacy of programmed death 1 (PD-1) inhibitors plus split-course radiotherapy in the first-line treatment of advanced kidney cancer. METHODS: In this prospective, randomized, single-blinded, controlled trial, 44 patients with advanced kidney cancer initially treated in our hospital from January 2017 to December 2018 were recruited. They were concurrently and randomly assigned at a ratio of 1 : 1 to the control group and the study group, with 22 cases in each group. The control group received PD-1 inhibitor nivolumab combined with ipilimumab, and the study group received split-course radiotherapy plus. The primary endpoint is clinical efficacy, and the secondary endpoints are progression-free survival (PFS), overall survival (OS), and adverse events (AEs). RESULTS: Nivolumab plus split-course radiotherapy was associated with an objective remission rate (ORR) of 59.09% versus nivolumab alone with an ORR of 27.27%. The median PFS was 21.5 months (95% CI: 14.1-NA) after single nivolumab therapy and 28.1 months (95% CI: 24.5-NA) after nivolumab plus split-course radiotherapy, with an HR of 1.875 (95% CI: 0.877-4.011). The median OS was 27.1 months (95% CI: 20.7-NA) after single nivolumab therapy and not reached after nivolumab plus split-course radiotherapy and an HR of 2.56 (95% CI: 1.081-6.06). Nivolumab was associated with significantly better OS plus split-course radiotherapy versus nivolumab alone. CONCLUSION: Nivolumab plus split-course radiotherapy in patients with advanced renal cell carcinoma significantly improves ORR and prolongs overall survival with a good safety profile. CI - Copyright (c) 2022 Weiping Li et al. FAU - Li, Weiping AU - Li W AUID- ORCID: 0000-0002-6760-922X AD - Department of Urology, The First Hospital of Lanzhou University, Lanzhou 730030, China. FAU - Cao, Zhigang AU - Cao Z AD - Department of Urology, The 940 Hospital of Joint Logistics Support Force of Chinese PLA, Lanzhou 730050, China. FAU - Chang, Pengcheng AU - Chang P AD - Department of Urology, The First Hospital of Lanzhou University, Lanzhou 730030, China. FAU - Zhang, Bin AU - Zhang B AUID- ORCID: 0000-0002-3743-4043 AD - Department of Urology, The 940 Hospital of Joint Logistics Support Force of Chinese PLA, Lanzhou 730050, China. FAU - Li, Fudong AU - Li F AD - Department of Urology, The 940 Hospital of Joint Logistics Support Force of Chinese PLA, Lanzhou 730050, China. FAU - Chang, Dehui AU - Chang D AD - Department of Urology, The 940 Hospital of Joint Logistics Support Force of Chinese PLA, Lanzhou 730050, China. LA - eng PT - Journal Article DEP - 20220730 PL - Egypt TA - J Oncol JT - Journal of oncology JID - 101496537 PMC - PMC9356868 COIS- The authors declare that they have no conflicts of interest. EDAT- 2022/08/10 06:00 MHDA- 2022/08/10 06:01 PMCR- 2022/07/30 CRDT- 2022/08/09 02:10 PHST- 2022/03/06 00:00 [received] PHST- 2022/05/06 00:00 [revised] PHST- 2022/05/16 00:00 [accepted] PHST- 2022/08/09 02:10 [entrez] PHST- 2022/08/10 06:00 [pubmed] PHST- 2022/08/10 06:01 [medline] PHST- 2022/07/30 00:00 [pmc-release] AID - 10.1155/2022/8100323 [doi] PST - epublish SO - J Oncol. 2022 Jul 30;2022:8100323. doi: 10.1155/2022/8100323. eCollection 2022.